MAUDE Adverse Event Report: COOPERSURGICAL, INC. KOH-EFFICIENT,RUMI,3.5CM

Model Number KC-ARCH-35

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Laceration(s) (1946)

Event Date 11/19/2021

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical, inc is currently investigating the reported condition.

Event Description

Vaginal laceration was found after the use of koh-efficient 3.5 cm.Such event had never been occurred before if a koh-cup-separated type was used.The patient is multiparous woman.Kc-rumi-35 koh-efficient,rumi,3.5cm e-complaint- (b)(4).

Manufacturer Narrative

Investigation: x-initiated manufacturer's investigation.X-no sample returned.X-review dhr.Analysis and findings: distribution history: the complaint product was manufactured at csi on 07/13/21 under work order 305318.Manufctrng record revw.Dhr - 305318 was reviewed and no non-conformities, related to the complaint condition, were noted.Incoming inspection revw.Incoming inspection record review not applicable to this product.Serv.History record: service history record not applicable to this product.Hist.Complaint revw.A review of the 2-year complaint history did show similar reported complaint condition.Product recpt: the complaint product has not been returned to coopersurgical.Visual eval: evaluation of the complaint product could not be completed as the complaint product has not been returned to coopersurgical.Functnl eval: evaluation of the complaint product could not be completed as the complaint product was not been returned to coopersurgical.However, the complaint condition is very similar to other complaints as mentioned earlier.Was the complaint confirmed? no.Root cause: no definitive root cause for this issue could be reliably determined at this time, with the information provided in the complaint.Complaint product was not returned for investigation.To mitigate cup detachment, csi stafford has implemented 100% in process inspection of the product via bend test, followed by an aql qc inspection requiring the units also pass bend/pull test.Correction and/or corrective action: coopersurgical will continue to monitor this complaint condition for trends.No further corrective action is necessary, as the root cause cannot be reliably determined with the information provided.No further training required at this time.

Event Description

Vaginal laceration was found after the use of koh-efficient 3.5 cm.Such event had never been occurred before if a koh-cup-separated type was used.The patient is multiparous woman.1216677-2021-00280 kc-rumi-35 koh-efficient,rumi,3.5cm (b)(4).

• Brand Name: KOH-EFFICIENT,RUMI,3.5CM
• Type of Device: KOH-EFFICIENT,RUMI,3.5CM
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer Contact: michael marone ; 50 corporate drive; trumbull, CT 06611 ; 4752651665
• MDR Report Key: 13023967
• MDR Text Key: 284287387
• Report Number: 1216677-2021-00280
• Device Sequence Number: 1
• Product Code: HEW
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K954311
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: KC-ARCH-35
• Device Catalogue Number: KC-ARCH-35
• Device Lot Number: 305318
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other